FDA de novo

By Dave Muoio February 19, 2019
Last week the FDA granted its first marketing authorization to an interoperable insulin pump that is compatible with automated insulin dosing systems, continuous glucose monitors, blood glucose meters and other diabetes therapy devices built by different manufacturers. The Tandem Diabetes Care t:Slim X2 insulin pump was reviewed through the De Novo premarket review pathway, making it the first of...

  (Photo by Drew Angerer/Getty Images)

By Laura Lovett January 8, 2019
The FDA unveiled new updates on the ongoing Pre-Cert program including a Digital Health Innovation Action Plan, Pre-Cert Test Plan for 2019 and a Working Model.  One of the big take aways from yesterday's announcement is that the FDA is looking to use the De Novo model to implement the next phase of the Pre-Cert pilot. The second is that the organization plans on setting up a parallel submission...
By Jonah Comstock September 13, 2018
Yesterday, Apple dropped a bombshell on the digital health world, as it is prone to do in its highly-produced launch events. While the announcement included fall detection on the Apple Watch and some improvements to heart rate monitoring, the headline was definitely the announcement that the Apple Watch Series 4 would contain an FDA-cleared ECG sensor. While much of the reaction has been positive...
By Jonah Comstock January 26, 2015
The old Dexcom Share, with charging cradle. Dexcom has received approval from the FDA for a new version of its smartphone connected Dexcom Share platform that will eliminate the docking cradle and allow a patient's continuous glucose monitor data to be transferred directly to a user's smartphone, as well as the smartphones of up to five friends or caretakers. Dexcom Share got clearance in...